NCT06331936

Brief Summary

The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 2, 2024

Last Update Submit

February 24, 2026

Conditions

Keywords

children in needteenagers from low socioeconomic familyrandomized wait-list control trial

Outcome Measures

Primary Outcomes (8)

  • 10-item Emotional Management Strategy Questionnaire

    Emotional management strategy questionnaire is a 10-item scale assessing parents' and children's emotional management strategy. Possible scores for each item range from 1 (not at all) to 6 (everyday). Higher scores indicate more frequent use of emotional management strategy.

    Baseline, week 4, week 8

  • 10-item Positive and Negative Affect Schedule

    Positive and negative affect schedule is a 10-item scale assessing parents' and children's positive and negative affect. Possible scores for each item range from 1 (not at all) to 6 (everyday). Higher scores indicate more positive or negative affect.

    Baseline, week 4, week 8

  • Patient Health Questionnaire-9

    Patient health questionnaire assesses the depressive symptoms among parents and children. Possible scores for each item range from 1 (not at all) to 4 (everyday). Higher scores indicate more depressive symptoms.

    Baseline, week 4, week 8

  • Generalized Anxiety Disorder Scale

    Generalized anxiety disorder questionnaire assesses the anxiety symptoms among parents and children. Possible scores for each item range from 1 (not at all) to 4 (everyday). Higher scores indicate more anxiety symptoms.

    Baseline, week 4, week 8

  • Subjective Happiness Scale

    Subjective happiness scale is a 4-item scale assessing parents' and children's subjective happiness. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate more subjective happiness.

    Baseline, week 4, week 8

  • Connor-Davidson Resilience Scale 10-Item

    Connor-Davidson resilience scale assesses the individual resilience among parents and children. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate greater resilience.

    Baseline, week 4, week 8

  • Child-Parent Relationship Scale

    Child-parent relationship scale is a 4-item scale assessing the relationship between parents and children. Possible scores for each item range from 1 (very dissatisfied) to 6 (very satisfied). Higher scores indicate better satisfaction with parents.

    Baseline, week 4, week 8

  • Family Harmony Scale

    Family harmony scale is an 8-item scale assessing the family harmony. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate better family harmony.

    Baseline, week 4, week 8

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm aims at improving children's emotional regulation skills.

Behavioral: Emotion regulation

Control Arm

NO INTERVENTION

The control arm participants will not receive any interventions.

Interventions

Each participant will attend four intervention sessions. They will also be invited to a booster Session, where they will be invited for interviews to share what they have gained from the sessions. The contents of the intervention and the booster session are as follows: (1) understand emotions, (2) attention and positivity, (3) emotional regulation, (4) connectedness and intimacy, and (5) review and sharing.

Intervention arm

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • single-parent families
  • low-income families
  • left-behind children

You may not qualify if:

  • a history of severe psychotic symptoms
  • have previously participated in a similar intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of Hong Kong

Hong Kong, China

Location

Related Publications (11)

  • Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.

    PMID: 18157881BACKGROUND
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PMID: 12964174BACKGROUND
  • Driscoll, K., & Pianta, R. C. (1992). Child-Parent Relationship Scale. Journal of Early Childhood and Infant Psychology. https://doi.org/10.1037/t16909-000

    BACKGROUND
  • Fabrizio CS, Lam TH, Hirschmann MR, Pang I, Yu NX, Wang X, Stewart SM. Parental emotional management benefits family relationships: A randomized controlled trial in Hong Kong, China. Behav Res Ther. 2015 Aug;71:115-24. doi: 10.1016/j.brat.2015.05.011. Epub 2015 Jun 4.

    PMID: 26112397BACKGROUND
  • Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatric Annals, 32(9), 509-515. https://doi.org/10.3928/0048-5713-20020901-06

    BACKGROUND
  • Lyubomirsky, S., Lepper, H.S. A Measure of Subjective Happiness: Preliminary Reliability and Construct Validation. Social Indicators Research, 46, 137-155 (1999). https://doi.org/10.1023/A:1006824100041

    BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND
  • Yu, N. X., Kam-fung Liu, I., & Bu, H. (2021). Enhancing resilience in cross boundary families: A parent-child parallel group intervention. Journal of Social Work, 21(4), 651-675. https://doi.org/10.1177/1468017320919103

    BACKGROUND
  • Yu X, Tam WW, Wong PT, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28.

    PMID: 21193179BACKGROUND
  • Zhang C, Wang T, Zeng P, Zhao M, Zhang G, Zhai S, Meng L, Wang Y, Liu D. Reliability, Validity, and Measurement Invariance of the General Anxiety Disorder Scale Among Chinese Medical University Students. Front Psychiatry. 2021 May 19;12:648755. doi: 10.3389/fpsyt.2021.648755. eCollection 2021.

    PMID: 34093269BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Nancy YU, Dr.

    City University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2024

First Posted

March 26, 2024

Study Start

January 6, 2024

Primary Completion

June 26, 2024

Study Completion

June 30, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

We will not make individual participant data available to other researchers.

Locations